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Indian court orders jail for 2 executives for shoddy drugs - 0 views

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    An Indian court has sentenced two pharmaceutical company executives to two-and-half years in jail for exporting substandard drugs to Vietnam a decade ago, months after the WHO linked their cough syrups to the deaths of children in Gambia. India suspended production at Maiden Pharmaceuticals in October last year for violations of manufacturing standards after the World Health Organization said four of its cough syrups may have killed dozens of children in Gambia. The company has denied its drugs were at fault for the deaths in Gambia and tests by an Indian government laboratory found there were no toxins in them. The company had been facing legal difficulties for years over suspected shoddy products. A court in Sonipat, near New Delhi, where Maiden has its main production facility, ordered jail for company founder Naresh Kumar Goel and technical director M.K. Sharma for exporting heartburn medicine "not of standard quality" to Vietnam.
pharmacybiz

India cancels licences of drug firms on fake products - 0 views

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    Indian authorities have cancelled or suspended licences of some domestic drug companies as part of action taken against 76 pharmaceutical firms this month for selling adulterated or fake products, a government source said on Thursday. India is known as the 'pharmacy of the world' and its pharmaceuticals exports have more than doubled over the past decade to $24.5 billion in 2021-22. But that image has been dented by the death of at least 70 children in Gambia and 19 children in Uzbekistan in Uzbekistan last year linked to drugs made by India-based pharmaceutical companies. Health Minister Mansukh Mandaviya confirmed a crackdown but did not give details of companies against which action had been taken. "There are more than 10,500 pharma companies in the country. Companies who make spurious medicine will not be spared," Mandaviya told reporters at an event. Licences of some Indian drug companies have been cancelled, some were suspended while others have been put on notice during the past 15 days, the source, who had direct knowledge of the matter, told Reuters news agency.
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Pharma Companies Face Suspension Amid Contamination Concerns - 0 views

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    The Indian government has suspended manufacturing in over 40 pharmaceutical companies based on a risk-based assessment conducted earlier in the year across 162 firms, according to the data provided by Union Health Minister Mansukh Mandaviya in Parliament on Thursday (Aug. 10). "Overall, a sum of 143 show-cause notices has been issued," Mandaviya said. There have been numerous recent incidents involving accusations from foreign countries regarding the contamination of syrups, eye drops, and ointments manufactured in India. Countries such as the Gambia, Uzbekistan, and Cameroon have linked the deaths of 70, 18, and six children, respectively, to cough syrups contaminated in India. Licenses for specific products have been either temporarily suspended or fully revoked for an additional 66 companies. In one case, an FIR has been registered, and in 21 cases, warning letters have been issued following inspections by both the Central Drugs Standard Control Organization and State authorities, the Minister added. Meanwhile, the Indian government has mandated rigorous testing for cough syrups before export. Starting June 1, any cough syrup must possess a government laboratory-issued certificate of analysis before being exported, the government said in a notice dated May 22.
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Indian Pharma Companies To Supply Oral Covid Drugs Globally - 0 views

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    Indian pharmaceutical companies are gearing up to become global suppliers of repurposed Covid-19 drugs. With the launch of new innovative Covid-19 oral drugs, Indian companies are again expected to grab opportunities in the global supply of oral Covid-19 drugs, according to data and analytics company GlobalData. As several countries witness increasing cases of Covid-19 despite vaccination, they have started booking supply orders for innovative Covid-19 treatments like antibody cocktails, monoclonal antibodies and the latest addition such Merck's the oral Covid-19 drug 'molnupiravir'. Prashant Khadayate, pharma analyst at GlobalData, comments: "Oral treatment for Covid-19 would be the most convenient option for the patients ranging from mild to moderate Covid-19 and would not require a hospital setting. Currently, a majority of the Covid-19 treatments require a hospital setting." According to GlobalData's Pharma Intelligence Center, the UK is the first country to approve molnupiravir which is in pre-registration stage in the US, EU and Japan.
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Dr. Reddy's GSL Histallay Hits UK Shelves! - 0 views

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    Indian multinational pharmaceutical company, Dr. Reddy's Laboratories has made its entry into the UK consumer health market with the launch of an over-the-counter allergy medication. Histallay (Fexofenadine Hydrochloride 120 mg tablets) is the company's first general sale list (GSL) product introduced in the UK market. Previously classified as a Prescription Only Medicine (POM), Dr. Reddy's Fexofenadine 120 mg is now available without prescription, under the brand name 'Histallay'. This allows people with allergic seasonal rhinitis (hay fever) to get direct access to the product via retail outlets such as pharmacies and supermarkets in the UK.
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India makes tests mandatory for cough syrup export - 0 views

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    India will make tests mandatory for cough syrups before they are exported, a government notice showed on Tuesday, after Indian-made cough syrups were linked to the deaths of dozens of children in Gambia and Uzbekistan. Any cough syrup must have a certificate of analysis issued by a government laboratory before it is exported, effective June 1, the government said in a notice dated May 22 and shared by the health ministry on Tuesday. India's $41 billion pharmaceutical industry is one of the biggest in the world but its reputation was shaken after the World Health Organization (WHO) found toxins in cough syrups made by three Indian companies. Syrups made by two of these companies were linked to the deaths of 70 children in Gambia and 19 in Uzbekistan last year. "Cough syrup shall be permitted to be exported subject to the export sample being tested and production of certificate of analysis," said the notice issued by the trade ministry. The health ministry did not immediately respond to a query on whether testing would be required for cough syrups sold in the domestic market.
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Cipla & Glenmark: FDA Recalls Impacting UK Market - 0 views

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    Two Indian pharmaceutical companies, Cipla and Glenmark, are pulling back certain products from the American market due to manufacturing concerns, according to the US Food and Drug Administration (USFDA). A New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution due to "short fill", news agency PTI reported, quoting the latest Enforcement Report issued by the US health regulator. Produced at the company's Indore SEZ plant, this medication is used to manage symptoms associated with lung diseases, such as asthma, chronic bronchitis and emphysema. Cipla USA decided to recall the affected lot following complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, the USFDA said, adding that the drug maker initiated the Class II recall in the US market on March 26 this year.
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